Date Initiated by Firm |
May 05, 2009 |
Date Posted |
November 20, 2009 |
Recall Status1 |
Terminated 3 on November 20, 2009 |
Recall Number |
Z-0371-2010 |
Recall Event ID |
53772 |
510(K)Number |
K032824
|
Product Classification |
Knee joint femorotibial metal/polymer non-constrained cemented prosthesis. - Product Code HSX
|
Product |
Stelkast Unicondylar Knee Femoral Component SC2462-1.
Used for moderate joint impairment from painful arthritis (rheumatoid, osteo and/or post-traumatic; revision of failed unicompartmental knee implant or other procedure; and alternative to tibial osteotomy in patients with unicompartmental arthritis. |
Code Information |
Lot number 20210-100108 |
Recalling Firm/ Manufacturer |
Stelkast Co 200 Hidden Valley Rd Mcmurray PA 15317-2659
|
For Additional Information Contact |
Linda Dunmire 724-941-6368
|
Manufacturer Reason for Recall |
incorrect size markings on component
|
FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
The recalling firm telephoned the medical supply companies on 5/5-19/09 to inform them of the problem and the need to return the products. If there are questions regarding this issue, please call 1.888.273.1583. |
Quantity in Commerce |
20 units |
Distribution |
Nationwide |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = HSX and Original Applicant = STELKAST COMPANY
|